OverviewThe Clinical Research Associate (CRA) supports clinical trial quality, compliance, and execution through site monitoring, study startup, data oversight, and regulatory documentation. The CRA will also serve as an in-house sponsor representative overseeing CROs and third-party monitoring vendors, ensuring delegated activities meet protocol, GCP, quality, and timeline requirements. This role will be supporting Phase I-III clinical trials , the ideal candidate will have experience in Oncology indications or I &I. The CRA will have the ability to work Hybrid work arrangement with Boston office MRTx requires a 70% office presence. .Availability for approximately 30–40% travel is required for site visits, co-monitoring, investigator meetings, and select international activities.ResponsibilitiesOversee CRO and vendor monitoring performance, including KPIs, monitoring quality, timelines, site risk, deviations, and CAPAs.Review monitoring visit reports and ensure findings and follow-up actions are appropriately documented and resolved.Conduct co-monitoring, for-cause, qualification, initiation, routine monitoring, and close-out visits as required.Perform SDV, SDR, remote monitoring, data review, query management, and data cleaning.Monitor site compliance with protocols, ICH GCP, FDA regulations, and applicable local requirements.Track and resolve site issues, protocol deviations, and CAPAs.Maintain and quality-check TMF and essential regulatory documents; support IRB/IEC submissions and renewals.Coordinate study startup activities, including feasibility, site selection, contracts, budgets, regulatory approvals, and site activation.Support investigator/site training, investigator meetings, data cuts, and study close-out activities.Maintain CTMS, EDC, eTMF, KPI, KRI, and risk-based monitoring tools.Collaborate with Clinical Operations, Regulatory, Data Management, Biostatistics, Pharmacovigilance, CROs, and clinical sites.Contribute to CSRs, regulatory submissions, study reports, dashboards, and vendor performance assessments.QualificationsBachelor’s degree in life sciences, nursing, pharmacy, or related field.4+ years of clinical monitoring experience, including at least 1 year of on-site CRA experience.Experience with sponsor oversight of CROs/third-party monitoring vendors, including KPI and performance management.Strong knowledge of ICH GCP, FDA regulations, and sponsor oversight requirements.Hands-on experience with EDC, CTMS, and eTMF systems; Medidata Rave strongly preferred.Valid driver’s license and passport with ability to travel 30–40%.Oncology clinical trial experience, particularly solid tumor or hematologic malignancies.Phase 1/2 experience, including SAD/MAD, PK/PD, or dose-escalation studies.Familiarity with RECIST 1.1 or other oncology endpoints.Experience with KPI dashboards and risk-based monitoring.SoCRA/CCRA or ACRP certification.Ability to work Hybrid work arrangement with Boston office 70% office presence. Availability for approximately 30–40% travel is required for site visits, co-monitoring, investigator meetings, and select international activities.Job SummaryID: 2026-1224Category: Clinical OperationsPosition Type: Regular Full-TimeMin: USD $95,000.00/Yr.Max: USD $125,000.00/Yr.
...Description Job Description:\n\nHome Health Aide (HHA incl. STNA, CNA, PCA, or DoDD DSP)SCHEDULE TYPE: PRN Only / As Needed\n\n \n PRN... ...are being provided. This includes specifications of contracted agencies for which services are being provided.\n CPR and First Aide...
...Part-Time: Mix of Evenings and Nights 2-3 shifts per week some weekends. Who Are We: Friendship Village, a premier Life Plan Community located... ...positive attitude toward customer service to act as a Security Officer for our Sunset Hills Campus. The right candidate...
...Job Description Job Description Description: Experienced Carrier Sales Representative Scottsdale, AZ About Edge Logistics Founded in 2014, Edge Logistics has grown into one of North America's fastest-growing transportation providers by combining technology...
...Medical Assistant Pediatrics OnPoint Pediatrics at Highlands Ranch | Highlands Ranch, CO Pay: $21$27 per hour OnPoint Medical Group is seeking an experienced, compassionate Medical Assistant to join our pediatric care team at OnPoint Pediatrics at Highlands...
...Pay: $14.00 per hour Job description: Driver / Conductor MIAMI internacional Airport Get Paid to Drive Brand-New Cars!$14.00 per hour Weekly Pay Call to set... ...Solutions provides staffing services for major car rental companies across the United States. Work with...